NEN EN 46001 : 1996
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
KWALITEITSSYSTEMEN - MEDISCHE APPARATUUR - BIJZONDERE EISEN VOOR DE TOEPASSING VAN EN 29001
01-12-2000
12-01-2013
Foreword
0 Introduction
1 Scope
2 Normative references
3 Definitions
4 Quality system requirements
4.1 Management responsibility
4.2 Quality system
4.3 Contract review
4.4 Design control
4.5 Document and data control
4.6 Purchasing
4.7 Control of customer-supplied product
4.8 Product identification and traceability
4.9 Process control
4.10 Inspection and testing
4.11 Control of inspection, measuring and test equipment
4.12 Inspection and test status
4.13 Control of nonconforming product
4.14 Corrective and preventive action
4.15 Handling, storage, packaging, preservation and delivery
4.16 Control of quality records
4.17 Internal quality audits
4.18 Training
4.19 Servicing
4.20 Statistical techniques
Annex A (informative) - Bibliography
Specifies the quality system requirements for the design/development, production, and where relevant, installation and servicing of medical devices.
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Superseded
|
| Standards | Relationship |
| EN 46001 : 1996 | Identical |
| DIN EN 46001:1996-09 | Identical |
| BS EN 46001:1997 | Identical |
| UNE-EN 46001:1996 | Identical |
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